BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO OX

    MDR report key: 11067566 · Received December 23, 2020

    Report

    Report Number
    2027541-2020-00002
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 9, 2020
    Report Date
    February 12, 2021
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    UDI-DI
    05700693938417
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF ANALYZER LOG REVIEW: THE TWO POINT CALIBRATION LOG SHOWS THAT THE CASSETTE WAS INSTALLED FROM (B)(6) 2020-(B)(6) 2020. THERE WERE NO K FAILURES THE ENTIRE TIME THE CASSETTE WAS INSTALLED. THE MANUAL QUALITY CONTROL (MQC) LOG INDICATES THAT MQC WAS NOT RUN ON THE SENSOR CASSETTE. THE RECOMMENDATION IS TO RUN MQC ON THE SENSOR CASSETTE PRIOR TO PATIENT TESTING PER ABL80 SERVICE MANUAL TO ENSURE THAT THE CASSETTE IS IN TESTABLE CONDITION. THE RETURNED SENSOR CASSETTE WAS EVALUATED AND TESTED . THE RESULTS SHOWED THAT THE PERFORMANCE OF THE SENSOR WAS WITHIN SPECIFICATIONS LIMITS FOR K+. THE SENSOR PASSED ALL LEVELS OF MQC. THE ROOT CAUSE INVESTIGATION HAS BEEN FINALIZED AND IT HAS NOT BEEN POSSIBLE TO IDENTIFY THE ROOT CAUSE WHICH REMAINS UNKNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, CUSTOMER COMPLAINS ABOUT ABL80 CO-OX WITH SERIAL NUMBER: (B)(6) DEVIATION ON PARAMETER K ABOUT CA. 2MMOL/L TOO HIGH COMPARED TO OTHER ABL80. ABL80 COOX. SN: (B)(6). K: 4.31 MMOL/L. ABL80 COOX . SN: (B)(6). K: 4.32 MMOL/L. ABL80 COOX . SN: (B)(6). K: 6.23 MMOL/L. DISCREPANCY: 6.23-4.31=1.92 MMOL/L (FALSE HIGH). THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY OR MALTREATMENT. ALSO, NO INFORMATION REGARDING GENDER, AGE, ETHNICITY OR RACE OF THE PATIENTS.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, CUSTOMER COMPLAINS ABOUT ABL80 CO-OX WITH SERIAL NUMBER: (B)(4) DEVIATION ON PARAMETER K. ABOUT CA. 2MMOL/L TOO HIGH COMPARED TO OTHER ABL80. ABL80 COOX SN: (B)(4): K: 4.31 MMOL/L. ABL80 COOX SN:(B)(4) K: 4.32 MMOL/L. ABL80 COOX SN:(B)(4) K: 6.23 MMOL/L. DISCREPANCY: 6.23-4.31=1.92 MMOL/L (FALSE HIGH). THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY OR MALTREATMENT. ALSO, NO INFORMATION REGARDING GENDER, AGE, ETHNICITY OR RACE OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526342 ABL80 FLEX CO OX ABL80 FLEX CO OX CHL SENDX MEDICAL, INC. 393-841 05700693938417

    Patients

    Seq Age Sex Outcome Treatment
    1